Novartis gets E.U. nod for bone drug Aclasta

AnitaGreil

ZURICH (MarketWatch) -- Drugmaker Novartis AG
NVS, -1.01%
said Friday that the European Union regulator had approved its bone drug Aclasta, a treatment which needs to be taken only once a year.

Novartis, based in Basel, said the E.U. approved Aclasta for the treatment of women with postmenopausal osteoporosis. It was recently approved in the U.S., where it's sold under the brand name Reclast.

Aclasta has been shown to reduce the risk of fractures in areas of the body typically affected by osteoporosis, including the hip, spine, wrists and hips.

It belongs to a type of drugs called bisphosphonates, which have long been used to treat osteoporosis, a condition which affects more than 50 million people in the E.U. and an estimated 44 million people in the U.S.

Osteoporosis is a symptom of aging. Bones start to become less dense in people who are in their late 30s, increasing the risk of fractures. Women suffer from osteoporosis more often than men, in part because they typically have less bone mass. The most devastating consequence of osteoporosis is fractures, especially hip fractures.

Aclasta is given as a 15-minute infusion once a year, while established drugs of this type are taken orally and more often, typically once a week or once a month. They are cumbersome to take, which leads to low compliance, and thereby compromises efficacy of the drug.

"Aclasta is highly effective at reducing fractures and can be given once-yearly which is a significant benefit to patients and clinicians," said Steven Boonen, Professor of Medicine at the Centre for Metabolic Bone Diseases & Division of Geriatric Medicine at the Leuven University in Belgium. "The convenience of a once-yearly dose should improve compliance and bone protection among patients while reducing fracture-related hospitalization and healthcare costs."

Karl Heinz Koch, pharmaceutical analyst at Swiss private bank Vontobel, expects the drug to generate around $1.2 billion in sales in 2011, an estimate based on an expected 10% market share.

He cautioned, though, that the drug's active ingredient will lose patent protection in 2011, which limits its contribution to Novartis's valuation.

Its shares have fallen 8.8% so far this year, underperforming the European sector average, which was flat. At 0805 GMT, they were down CHF0.30, or 0.5%, at CHF63.70, in an unchanged broader market

The European approval had no impact on the shares Friday, because it was widely expected after a scientific advisory body for the E.U. recommended it for approval. But they came under pressure in early trading because Canada's health regulator said Thursday that it will pull Novartis' painkiller Prexige from the market on safety concerns.

The drug was already pulled in Australia a few months ago, and was recently denied marketing approval in the U.S.

"We are looking at our sales projection for Prexige, which currently stands at CHF450 million," Vontobel's Koch said, because other countries may also withdraw the drug.

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